|
|
 |
Abstract
Superior outcome for tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV in antiretroviral naïve patients
Pozniak A.L.1, Gallant J.E.2, DeJesus E.3, Campo R.4, Arribas J.R.5, Gazzard B.1, Lu B.6, McColl D.6, Enejosa J.6, Cheng A.K.6
1Chelsea and Westminster Hospital, London, United Kingdom, 2Johns Hopkins University School of Medicine, Baltimore, United States of America, 3Orlando Immunology Center, Orlando, United States of America, 4University of Miami, Miami, United States of America, 5University Hospital La Paz, Madrid, Spain, 6Gilead Sciences, Foster City, United States of America
Introduction: This is the first trial comparing once daily TDF, FTC and efavirenz (EFV) to twice daily CBV and EFV once daily.
Methods: Ongoing 96-week, phase III, open-label non-inferiority trial in treatment naïve patients with HIV RNA > 10,000 c/mL. Patients were randomized to receive TDF, FTC and EFV or CBV+EFV. The primary efficacy endpoint was the proportion of patients achieving and maintaining HIV RNA < 400 c/mL at week 48 using the FDA Time to Loss of Virologic Response (TLOVR) algorithm.
Results: The ITT population (n=509) had a mean age of 38 years, mean HIV RNA 5.0 log10 c/mL, mean CD4 245/mm3 and was 86% male. Preliminary analyses demonstrated that using the TLOVR algorithm, 81% in the TDF+FTC arm (n=255) vs 71% in the CBV arm (n=254) achieved and maintained HIV RNA < 400 c/mL through Week 48 (95% CI +3.4% to +18.1%, p =0.005). Virologic rebound occurred in <1% of patients in the TDF+FTC arm vs. 4% of CBV patients, p =0.021. Similarly, 77% in the TDF+FTC arm vs 69% in the CBV arm achieved and maintained HIV RNA < 50 c/mL through Week 48 (95% CI +0.5% to +15.8%, p = 0.042). The increase in CD4 count from baseline was significantly greater in the TDF+FTC arm (189 cells/mm3 vs. 158, p = 0.002). Adverse events leading to study regimen discontinuation (most common: anemia, nausea, fatigue, vomiting) were fewer for TDF+FTC arm (4%) vs CBV arm (9%), p = 0.016. No patient discontinued study regimen due to renal adverse events. No patient developed the K65R mutation.
Conclusions: Through week 48, the combination of TDF, FTC and EFV compared to CBV + EFV fulfilled the criteria for non inferiority and resulted in a superior outcome in terms of virologic suppression, CD4 response, and adverse events leading to study regimen discontinuation.
Back
|